Spinal Excitation to Enhance Mobility
2 other identifiers
interventional
23
1 country
1
Brief Summary
Older adults with compromised walking ability have higher rates of morbidity and mortality, more hospitalizations, poorer quality of life, and are less likely to remain independent in the community. It is known that age-related changes in brain and peripheral nerves contribute to loss of walking ability. However, there is a lack of research into how the aging spinal cord affects walking. In older adults, the spinal cord is less excitable, conducts signals more slowly, and is subject to neural noise. Intervening on age-related impairment of the spinal cord to improve walking ability is a very promising but untapped area of research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2018
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
December 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2021
CompletedResults Posted
Study results publicly available
July 28, 2023
CompletedSeptember 13, 2023
August 1, 2023
2.7 years
September 6, 2018
September 7, 2022
August 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Walking Speed Change From Baseline
Fastest safe walking speed over the complex walking course (measured as changed between the baseline and follow-up sessions)
Measured at session 2 (2 days after the baseline session)
Secondary Outcomes (1)
Prefrontal fNIRS Change From Baseline
Measured at session 2 (2 days after the baseline session)
Study Arms (4)
tsDCS Dosage A and textured insoles
EXPERIMENTALtsDCS dosage "A" and textured shoe insoles
tsDCS Dosage B and textured insoles
EXPERIMENTALtsDCS dosage "B" and textured shoe insoles
tsDCS Dosage A and smooth insoles
EXPERIMENTALtsDCS dosage "A" and smooth shoe insoles
tsDCS Dosage B and smooth insoles
EXPERIMENTALtsDCS dosage "B" and smooth shoe insoles
Interventions
mild electrical stimulation delivered to lumbosacral spinal cord
mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles
Eligibility Criteria
You may qualify if:
- Preferred 10m walking speed \< 1.0 m/s
- Intact tactile sensation based on two-point discrimination
- Willingness to be randomized to either intervention and to participate in all aspects of study assessment and intervention
You may not qualify if:
- Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition
- spinal cord injury
- Alzheimer's
- Parkinson's
- stroke, etc.
- Contraindications to non-invasive spinal stimulation including any prior spinal surgical procedure
- Chronic lower back pain
- Obesity, defined as Body Mass Index exceeding 30.
- This is due to the potential influence of body fat on the amplitude of electrical current flow to the spinal cord.
- Use of medications affecting the central nervous system including, but not limited to:
- benzodiazepines
- anti-cholinergic medication and GABAergic medication
- Severe arthritis, such as awaiting joint replacement
- Current cardiovascular, lung or renal disease
- Diabetes
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608, United States
Related Publications (1)
Clark DJ, Hawkins KA, Winesett SP, Cox BA, Pesquera S, Miles JW, Fuller DD, Fox EJ. Enhancing Locomotor Learning With Transcutaneous Spinal Electrical Stimulation and Somatosensory Augmentation: A Pilot Randomized Controlled Trial in Older Adults. Front Aging Neurosci. 2022 Mar 2;14:837467. doi: 10.3389/fnagi.2022.837467. eCollection 2022.
PMID: 35309891RESULT
Results Point of Contact
- Title
- Dr. David Clark
- Organization
- Malcom Randall VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
David J. Clark, DSc
North Florida/South Georgia Veterans Health System, Gainesville, FL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be masked to the dosage of transcutaneous spinal direct current stimulation (tsDCS)
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2018
First Posted
September 12, 2018
Study Start
December 17, 2018
Primary Completion
August 18, 2021
Study Completion
August 18, 2021
Last Updated
September 13, 2023
Results First Posted
July 28, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The Limited Dataset will be available after the study is completed.
A Limited Dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.